Wright Medical Technology, Inc Cherry Road Memphis, TN

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1 Wright Medical Technology, Inc Cherry Road Memphis, TN Wright Medical EMEA Atlas Arena, Australia Building Hoogoorddreef BA Amsterdam the Netherlands Trademarks and Registered marks of Wright Medical Technology, Inc Wright Medical Technology, Inc. All Rights Reserved A_19-May-2015

2 EVOLVE Radial Head Plate SURGIC A L T ECHNIQUE

3 EVOLVE Radial Head Plate surgical technique as described by JOHN T. CAPO, MD VIRAK TAN, MD Proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training and experience. Prior to use of the system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects. Package inserts are also available by contacting Wright Medical Technology, Inc.

5 ORDERING information EVOLVE RADIAL HEAD PLATE IMPLANTS PART NUMBER DESCRIPTION KIT QTY 4910S001 EVOLVE Proximal Radial Head Plate - Std Sz S002 EVOLVE Proximal Radial Head Plate - Std Sz S003 EVOLVE Proximal Radial Head Plate - Std Sz S004 EVOLVE Proximal Radial Head Plate - Std Sz L001 EVOLVE Proximal Radial Head Plate - Long Sz L002 EVOLVE Proximal Radial Head Plate - Long Sz L003 EVOLVE Proximal Radial Head Plate - Long Sz L004 EVOLVE Proximal Radial Head Plate - Long Sz LOCKING CANCELLOUS BONE SCREW 2.0MM (14MM) LOCKING CANCELLOUS BONE SCREW 2.0MM (16MM) LOCKING CANCELLOUS BONE SCREW 2.0MM (18MM) LOCKING CANCELLOUS BONE SCREW 2.0MM (20MM) LOCKING CANCELLOUS BONE SCREW 2.0MM (22MM) LOCKING CANCELLOUS BONE SCREW 2.0MM (24MM) LOCKING CANCELLOUS BONE SCREW 2.0MM (26MM) LOCKING CANCELLOUS BONE SCREW 2.0MM (28MM) CANCELLOUS SCREW CRUCIFORM DRIVE 2.0 (12MM) CANCELLOUS SCREW CRUCIFORM DRIVE 2.0 (14MM) CANCELLOUS SCREW CRUCIFORM DRIVE 2.0 (16MM) CANCELLOUS SCREW CRUCIFORM DRIVE 2.0 (18MM) CANCELLOUS SCREW CRUCIFORM DRIVE 2.0 (20MM) CANCELLOUS SCREW CRUCIFORM DRIVE 2.0 (22MM) CANCELLOUS SCREW CRUCIFORM DRIVE 2.0 (24MM) CANCELLOUS SCREW CRUCIFORM DRIVE 2.0 (26MM) CANCELLOUS SCREW CRUCIFORM DRIVE 2.7 (12MM) CANCELLOUS SCREW CRUCIFORM DRIVE 2.7 (14MM) CANCELLOUS SCREW CRUCIFORM DRIVE 2.7 (16MM) CANCELLOUS SCREW CRUCIFORM DRIVE 2.7 (18MM) CANCELLOUS SCREW CRUCIFORM DRIVE 2.7 (20MM) CANCELLOUS SCREW CRUCIFORM DRIVE 2.7 (22MM) CANCELLOUS SCREW CRUCIFORM DRIVE 2.7 (24MM) CANCELLOUS SCREW CRUCIFORM DRIVE 2.7 (26MM) K-WIRE DRILL BIT 1.5MM DRILL BIT 2.0MM 1 INSTRUMENTS DRILL GUIDE 1.5MM/ 2.0MM QUICK CONNECT HANDLE MINI SCREW DEPTH GAUGE EVOLVE LOCKING DRILL GUIDE 1.5mm EVOLVE BONE TAP 2.7mm CRUCIFORM DRIVER RADIAL HEAD PLATE EVOLVE RHP SIZER TRAY EVOLVE RADIAL HEAD PLATE SIZER, SIZE 1/ EVOLVE RADIAL HEAD PLATE SIZER, SIZE 3/ EVOLVE RADIAL HEAD PLATE HEAD BENDER EVOLVE RADIAL HEAD PLATE STEM BENDER SCREW GRASPER 1 SURGICAL TRAY INSTRUMENT TRAY AND SCREW CADDIE 1 twelve

EVOLVE Radial Head Plate as described by John T. Capo, MD and Virak Tan, MD GENERAL PRECAUTIONS Proper surgical procedures and techniques are the responsibility of the medical professional.

6 EVOLVE Radial Head Plate as described by John T. Capo, MD and Virak Tan, MD GENERAL PRECAUTIONS Proper surgical procedures and techniques are the responsibility of the medical professional. Each surgeon must evaluate the appropriateness of the procedure used based on personal medical training and experience. Wright Medical Technology, Inc. cannot recommend a particular surgical technique suitable for all patients. DEVICE DESCRIPTION The EVOLVE Radial Head Plate is a low-profile device designed for secure, fixed-angle fixation of radial head fractures. The fixed-angle locking screws are designed to provide buttressing support of the radial head, even in the presence of limited comminution. All implant components are manufactured from surgical-grade Stainless Steel for maximum strength and fatigue life. The outer surface is highly polished to resist adhesion to the overlying soft tissue structures. INDICATIONS Operative exposure of the fracture becomes necessary if acceptable reduction cannot be achieved by closed means or in those high-energy injuries in which extensive soft tissue or associated skeletal injury requires stable fixation of the radial head. There are several fracture types that may require open reduction and internal fixation: Comminuted radial head fractures with good bone stock and adequate fracture size. Intra-articular radial head fractures with significant displacement. Radial neck fracture with significant angulation or displacement. Unstable elbow fracture dislocations with Lateral and Medial Collateral Ligament injuries. CONTRAINDICATIONS Contraindications may include, but are not limited to the following: Severe comminution with lack of adequate fracture size Severe medical illnesses Patient unreliability Localized septic process Massive soft tissue swelling Lack of basic equipment Unfamiliarity with the surgical approaches one

PREOPERATIVE PLANNING Radiographs of both the injured and contralateral non-injured limbs can be helpful with pre-operative surgical planning.

$In the event that the fracture pattern does not permit adequate fixation of fragments, the surgeon should be prepared to replace the radial head with an implant such as the EVOLVE Radial Head$

7 PREOPERATIVE PLANNING Radiographs of both the injured and contralateral non-injured limbs can be helpful with pre-operative surgical planning. In many circumstances, it is difficult to determine pre-operatively whether ORIF of the radial head will be feasible. In the event that the fracture pattern does not permit adequate fixation of fragments, the surgeon should be prepared to replace the radial head with an implant such as the EVOLVE Radial Head Prosthesis. Clinical studies have demonstrated the benefits of radial head replacement over resection, including preservation of the radial length and maintenance of elbow valgus stability. 1,2,3 FIGURE 1 SURGICAL TECHNIQUE STEP 1 - PATIENT PREPARATION A modified Kocher approach is the preferred exposure for plating of the radial head. Complex elbow fractures or dislocations may dictate the use of an alternate exposure. For the modified Kocher approach, the patient is placed in a supine position and the injured arm supported by a hand table. The initial incision is made through the distal portion of the lateral column FIGURE 1. Once skin flaps have been raised, the lateral supracondylar ridge of the distal humerus is identified FIGURE 2. FIGURE 2 Dissection is performed through the common extensor mass onto the joint capsule, staying anterior to the mid-axis of the radial head to avoid disruption of the Lateral Ulnar Collateral Ligament (LUCL). The supinator muscle is then visualized and its proximal fibers are divided. If an extended exposure is necessary (i.e. greater than 3.5cm distal to the radiocapitellar joint line), the posterior interosseous nerve should be identified in the supinator muscle. two

8 Screw Caddy Convenient Color-Coding Locking Drill Guide Quick-Connect Handle 1.5mm/2.0mm Drill Guide Screw Grasper In Situ Sizers Depth Gauge Plate Bender Plate Bender Sizing Tray eleven

STEP 7 - CLOSURE - POST OP The wound is irrigated before closure. The capsule is sutured in an interrupted manner with a #0 or larger braided nonabsorbable suture.

9 STEP 7 - CLOSURE - POST OP The wound is irrigated before closure. The capsule is sutured in an interrupted manner with a #0 or larger braided nonabsorbable suture. The competence of the LUCL should be assessed and repaired if compromised by injury or the surgical approach. This can be accomplished with heavy sutures, drill holes or suture anchors. The skin is closed in layers. Postoperatively, the arm is started on immediate range of motion under the guidance of a trained therapist (if not precluded by other injuries of the elbow) FIGURE 24. FIGURE 24 REFERENCES 1 King GJ. Management of Radial Head Fractures With Implant Arthroplasty. J Am Soc Surg Hand 2004 Feb; Vol.4 No.1: REPRINTS AVAILABLE FROM WRIGHT MEDICAL: PART NUMBER SO Beingessner DM, Dunning CE, Gordon KD, Johnson JA, King GJ. The effect of radial head excision and arthroplasty on elbow kinematics and stability. J Bone Joint Surg Am 2004 Aug;86-A(8): King GJ, Zarzour ZD, Rath DA, Dunning CE, Patterson SD, Johnson JA. Metallic radial head arthroplasty improves valgus stability of the elbow. Clin Orthop 1999 Nov(368): ten

The lateral joint line is exposed by dividing the capsule longitudinally across the annular ligament, in line with the superficial dissection

FIGURE 3 FIGURE 3 STEP 2 - IMPLANT SIZING The EVOLVE Radial Head Plate sizes correspond with the most commonly used EVOLVE Prosthesis head

10 The lateral joint line is exposed by dividing the capsule longitudinally across the annular ligament, in line with the superficial dissection and anterior to the LUCL complex. FIGURE 3 FIGURE 3 STEP 2 - IMPLANT SIZING The EVOLVE Radial Head Plate sizes correspond with the most commonly used EVOLVE Prosthesis head diameters FIGURE 4. FIGURE 4 Corresponding EVOLVE Radial Head Plate Size Prosthesis Head Diameter (mm) The correctly sized plate will conform closely to the underlying bone of the reconstructed radial head FIGURE 5. FIGURE 5 three

$The short plate is appropriate for most fractures and allows for a smaller exposure; however, the longer plates are appropriate for fractures with more extensive$ neck and shaft involvement.

11 There are also long and short versions of each plate FIGURE 6. The short plate is appropriate for most fractures and allows for a smaller exposure; however, the longer plates are appropriate for fractures with more extensive neck and shaft involvement. 35mm 39mm FIGURE 6 Large, free fragments of the radial head may be removed from the surgical site and used to determine the correct plate size with the sizing tray (P/N ) FIGURE 7. FIGURE 7 Alternatively, if the surgeon prefers not to remove fragments from the surgical site, the plate size may be determined with the in-situ sizers (P/N and ) FIGURE 8. FIGURE 8 four

STEP 6 - SHAFT FIXATION The screw holes in the shaft portion of the plate are designed to receive 2.

$neck fracture line before final screw placement FIGURE 22. The remainder of the screws are then placed as described above.$

12 STEP 6 - SHAFT FIXATION The screw holes in the shaft portion of the plate are designed to receive 2.7mm cortical screws, which can be used for bicortical fixation. The procedure is the same as for the 2.0mm non-locking screws, except the 2.0mm drill (P/N ) is used with the corresponding end of the variable angle drill guide FIGURE 21. FIGURE 21 By placing the first screw in the elliptical shaft hole, position of the plate can be adjusted for compression across the radial neck fracture line before final screw placement FIGURE 22. The remainder of the screws are then placed as described above. FIGURE 22 Flouroscopy is used to confirm final fracture reduction and hardware position. The elbow is taken through a full range of motion to ensure that there is no impingement or impedance of motion FIGURE 23. FIGURE 23 nine

Screw length is verified with the gauge on the screw caddy; with the tip of the screw at the 0 line, the measurement is taken at the top of the screw head FIGURE 18.

This screw will set the plate in close apposition to bone, and may be removed later and replaced with a 2.0mm locking screw if necessary.

The elliptical slot where the head of the plate meets the stem can be used in several ways: To provide additional purchase into the head fragments As an interfragmentary screw from the shaft

13 Screw length is verified with the gauge on the screw caddy; with the tip of the screw at the 0 line, the measurement is taken at the top of the screw head FIGURE 18. The first screw to be inserted should be a 2.0mm NON-LOCKING screw in one of the locking screw holes. This screw will set the plate in close apposition to bone, and may be removed later and replaced with a 2.0mm locking screw if necessary. FIGURE 18 The plate should then be securely attached to the radial head using as many 2.0mm screws as necessary. The elliptical slot where the head of the plate meets the stem can be used in several ways: To provide additional purchase into the head fragments As an interfragmentary screw from the shaft into the head For bicortical fixation of the radial shaft It is also possible to freehand the 2.0mm non-locking screws outside the plate to retain difficult fragments, provided that the heads are buried beneath the articular cartilage FIGURE19. FIGURE 19 If the plate and radial head fragments have been assembled ex-vivo, the entire assembly is placed back in the surgical site and approximated to the shaft of the radius FIGURE 20. FIGURE 20 eight

STEP 3 - REDUCTION AND PLATE POSITIONING In most cases, the precontoured plate will not need to be bent.

However, do not exceed 10 degrees of bending, and bend in one direction only.

The plate should be placed directly opposite the Proximal Radial Ulnar Joint (PRUJ). This position is directly lateral with the forearm in neutral rotation.

14 STEP 3 - REDUCTION AND PLATE POSITIONING In most cases, the precontoured plate will not need to be bent. If necessary, fine adjustments in plate contour may be performed with the Plate Benders (P/N and ) FIGURE 9. However, do not exceed 10 degrees of bending, and bend in one direction only. FIGURE 9 If fragments can be reduced directly, the EVOLVE plate may be applied directly to the radius and provisionally fixed with a K-wire (P/N ) FIGURE 10. The plate should be placed directly opposite the Proximal Radial Ulnar Joint (PRUJ). This position is directly lateral with the forearm in neutral rotation. It is imperative that the plate be placed within the safe zone of the PRUJ so it does not impede forearm rotation. This zone is in line with Lister s Tubercle, on the direct dorsal surface of the radius. FIGURE 10 If the fragments cannot be reduced in-situ in a stable fashion, they may be removed and reassembled on the back table using the sizing tray, K-wires and the EVOLVE plate. FIGURE 11. Following screw placement described below, the entire plate/bone assembly may then be transferred to the surgical site. FIGURE 11 five

2.0mm Cancellous Screw 1.5mm 1.1 drill 2.7mm Cortical Cancellous Screw Screw 2.0mm drill 2.0mm Locking Screw 1.5mm 1.1 drill STEP 4 - HEAD SCREW PREPARATION Correct screw and drill usage is shown in FIGURE 12.

The two central holes can receive either locking or non-locking screws; the locking screws will provide fixed-angle fixation of the radial head, while the non-locking screws will lag the plate down

15 2.0mm Cancellous Screw 1.5mm 1.1 drill 2.7mm Cortical Cancellous Screw Screw 2.0mm drill 2.0mm Locking Screw 1.5mm 1.1 drill STEP 4 - HEAD SCREW PREPARATION Correct screw and drill usage is shown in FIGURE 12. The screw holes in the head portion of the plate are designed to receive 2.0mm cancellous screws, which are placed in a unicortical fashion. Care must be taken not to perforate into the PRUJ. The two central holes can receive either locking or non-locking screws; the locking screws will provide fixed-angle fixation of the radial head, while the non-locking screws will lag the plate down to the bony surface. The elongated outboard holes in the head of the plate receive only non-locking screws, which can be directed to retain difficult fragments. FIGURE 12 To prepare for 2.0mm locking screws, the locking drill guides must be used (P/N ). The locking screw holes are manufactured parallel to one another, and care should be taken to thread the locking drill guide in the proper orientation FIGURE 13. FIGURE 13 Using the 1.5mm drill (P/N ), drill up to (but not through) the opposing cortex in both locking screw holes FIGURE 14. To prepare for the 2.0mm non-locking screws, the 1.5mm drill is used with the corresponding end of the variable angle drill guide (P/N ). FIGURE 14 six

All drill guides must be removed prior to measuring screw length with the depth

FIGURE 15 STEP 5 - HEAD SCREW PLACEMENT Screws are delivered to the operative site

To pick up the screws, the driver is pressed firmly into the screw head while the

16 All drill guides must be removed prior to measuring screw length with the depth gauge (P/N ) FIGURE 15. FIGURE 15 STEP 5 - HEAD SCREW PLACEMENT Screws are delivered to the operative site using the self-retaining cruciform driver (P/N ). To pick up the screws, the driver is pressed firmly into the screw head while the screw is still in the caddy FIGURE 16. FIGURE 16 Alternatively, the screws may be picked up with the aid of the screw grasper (P/N ) FIGURE 17. FIGURE 17 seven

Locking Radial Head Plates

Locking Radial Head Plates Locking Radial Head Plates Since 1988, Acumed has been designing solutions to the demanding situations facing orthopaedic surgeons, hospitals and their patients. Our strategy